Therapeutic effect of physical and cognitive training combined with melatonin supplementation in subjects with mild to moderate Parkinson's disease.

The effect of physical activity and simultaneous cognitive enrichment coupled with melatonin supplementation on cognitive-motor performance and biochemical adaptations in subjects with mild to moderate Parkinson's disease.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202309885617364

Enrollment

Registered

2023-09-01

Start date

2023-04-15

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nervous System Diseases

Interventions

simultaneous physical and cognitive exercice combined with melatonin supplementation

Patients of this group will be included of neurological rehabilitation which is composed of physical

placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Have mild to moderate Parkinson's disease. • Be 50 or older. • Subjects not undergoing other types of physical or cognitive interventions.

Exclusion criteria

Exclusion criteria: • Illiterate subjects. • With a chronic pathology that could affect their capacity for effort or the evaluation of walking parameters, balance or cycling: recent and/or unstable respiratory, neurological or musculoskeletal, cardiovascular pathologies ( e.g. heart attack, arrhythmia, angina pectoris, hypertension), insulin-dependent diabetes, or alcoholism or presenting contraindications to taking melatonin. • Advanced stage of Parkinson's disease.

Design outcomes

Primary

Measure	Time frame
physical performance evaluated by 10 m of walking test,postural balance by AMTI force plate,functional capacity measured by timed up and go,30 secondes sit to stand test and four square step test and cognitive performance evaluated by Montreal Cognitive Assessment (MoCA),Trail making test TMT-A,TMT-B,symbol digit modalities SDMT,verbal fluency,stroop test.Biochemial adaptations evaluated by oxidative stress and routine biochemical assessment.	—

Measure

Time frame

physical performance evaluated by 10 m of walking test,postural balance by AMTI force plate,functional capacity measured by timed up and go,30 secondes sit to stand test and four square step test and cognitive performance evaluated by Montreal Cognitive Assessment (MoCA),Trail making test TMT-A,TMT-B,symbol digit modalities SDMT,verbal fluency,stroop test.Biochemial adaptations evaluated by oxidative stress and routine biochemical assessment.

—

Secondary

Measure	Time frame
sleep quality evaluated by Pittsburgh Sleep Quality Index (PSQI),quality of life by parkinson disease questionnaire PDQ-8,depression by Hospital Anxiety and Depression Scale.	—

Countries

Tunisia

Contacts

Public ContactMeryam Ben yahia

PhD Student at Higher Institute of Sport and Physical Education of Sfax

Meryambenyahia96@gmail.com+21629273751

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026